Post-Approval Studies

Post-Approval Studies

In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).

The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.

CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.

In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.

Patients undergoing treatment for AAA with the Zenith fenestrated AAA endovascular graft who completed training program; no control group
Patients undergoing treatment for AAA with the Zenith fenestrated AAA endovascular graft who completed training

program; no control group

Sample Size

82 subjects; no controls

Data Collection

Technical success of implant

Followup Visits and Length of Followup

None

None

Final Study Results

Actual Number of Patients Enrolled

82

Actual Number of Sites Enrolled

47

Patient Followup Rate

100%

Final Safety Findings

No safety endpoints in this study

Final Effectiveness Findings

Technical success rate if implantation = 91.5%

Study Strengths and Weaknesses

There was 100% follow쳌]up of study subjects, and endpoint was fully assessed in all subjects. The primary endpoint was met by a wide margin. There were no significant weaknesses in this study.
There was 100% follow쳌]up of study subjects, and endpoint was fully assessed in all subjects.

The primary endpoint was met by a wide margin. There were no significant weaknesses in this study.

Recommendations for Labeling Changes

No labeling change is recommended because there is no new information that is thought to be of sufficient value to justify a labeling change.
No labeling change is recommended because there is no new information that is thought to